MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR 2 CANNULA; CAT

Model Number OJR414

Device Problems Material Separation (1562); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint cannula is currently en route to fisher & paykel healthcare (b)(4) for evaluation.We are in process to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that the ojr414 optiflow junior 2 nasal cannula "came apart where the cannula tubing meets the wiggle pads".There was no patient consequence.

Manufacturer Narrative

Ps303869 method: the complaint ojr414 optiflow junior 2 nasal cannula was returned to fisher & paykel healthcare (f&p) in new zealand for investigation where it was visually inspected.Results: visual inspection of the complaint cannula revealed that one tubing was damaged near the cannula joint and the cannula showed signs of being used.Conclusion: we are unable to determine conclusively the cause of the reported event.However, the damage to the cannula is most likely to have been caused by having the tubing inadvertently pulled.All optiflow junior 2 cannulae are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken and pull tested to check glue joint strength at the cannula/tube joint.If there are any failures the entire batch is put aside for further investigation.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 nasal cannula.They also state the following: - appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.- do not wrap, insulate, stretch or crush the tubing as this may impair the performance of this product or compromise safety (including potentially causing patient harm).

Event Description

A hospital in virginia reported that the ojr414 optiflow junior 2 nasal cannula "came apart where the cannula tubing meets the wiggle pads".There was no patient consequence.

• Brand Name: OPTIFLOW JUNIOR 2 CANNULA
• Type of Device: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8458743
• MDR Text Key: 140152155
• Report Number: 9611451-2019-00286
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OJR414
• Device Catalogue Number: OJR414
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1